FDA.reportPublic FDA data

hydrocodone bitartrate and acetaminophen

Product NDC
71930-042
11-digit product format
719300042
Labeler code
71930
Product ID
71930-042_81111908-961b-431d-ac76-379df2ea1406
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocodone bitartrate and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Eywa Pharma Inc
Application
ANDA207509
Marketing category
ANDA
Marketing start
2019-06-17
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
300; 5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
hydrocodone bitartrate and acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN300 mg/1
HYDROCODONE BITARTRATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNO70W886KK, 362O9ITL9D
Rxcui856980, 856987, 856992

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
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06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
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e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
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23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71930-042-12hydrocodone bitartrate and acetaminophen100 in 1 BOTTLETABLET1007
71930-042-52hydrocodone bitartrate and acetaminophen500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71930-042-12EA - Each71930-04291fd15e4-9c90-413a-aac5-1a7893ef283612019-08-06
71930-042-52EA - Each71930-042e777c356-2d11-4015-84cd-c9630767095512019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71930-042HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [EYWA PHARMA INC]4Current NDC, Legacy NDC, 2 package rows20240830_8a201e19-3e47-7e58-e053-2995a90ab1d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856987HYDROcodone bitartrate 5 MG / acetaminophen 300 MG Oral TabletPSN68c97e24-6898-4c17-813b-e1e62f56cb65102
856987acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral TabletSCD68c97e24-6898-4c17-813b-e1e62f56cb65102
856987APAP 300 MG / hydrocodone bitartrate 5 MG Oral TabletSY68c97e24-6898-4c17-813b-e1e62f56cb65102
856980HYDROcodone bitartrate 10 MG / acetaminophen 300 MG Oral TabletPSN8a201e19-3e47-7e58-e053-2995a90ab1d57
856987HYDROcodone bitartrate 5 MG / acetaminophen 300 MG Oral TabletPSN8a201e19-3e47-7e58-e053-2995a90ab1d57
856992HYDROcodone bitartrate 7.5 MG / acetaminophen 300 MG Oral TabletPSN8a201e19-3e47-7e58-e053-2995a90ab1d57
856980acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral TabletSCD8a201e19-3e47-7e58-e053-2995a90ab1d57
856987acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8a201e19-3e47-7e58-e053-2995a90ab1d57
856992acetaminophen 300 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD8a201e19-3e47-7e58-e053-2995a90ab1d57
856980APAP 300 MG / hydrocodone bitartrate 10 MG Oral TabletSY8a201e19-3e47-7e58-e053-2995a90ab1d57
856987APAP 300 MG / hydrocodone bitartrate 5 MG Oral TabletSY8a201e19-3e47-7e58-e053-2995a90ab1d57
856992APAP 300 MG / Hydrocodone Bitartrate 7.5 MG Oral TabletSY8a201e19-3e47-7e58-e053-2995a90ab1d57
856980HYDROcodone bitartrate 10 MG / acetaminophen 300 MG Oral TabletPSNc648e299-2a8b-4530-a061-c6fd9cd1294c4
856987HYDROcodone bitartrate 5 MG / acetaminophen 300 MG Oral TabletPSN2f6d0712-e756-49f2-a6b8-bbd160a454c44
856987HYDROcodone bitartrate 5 MG / acetaminophen 300 MG Oral TabletPSNc648e299-2a8b-4530-a061-c6fd9cd1294c4
856992HYDROcodone bitartrate 7.5 MG / acetaminophen 300 MG Oral TabletPSNc648e299-2a8b-4530-a061-c6fd9cd1294c4
856980acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral TabletSCDc648e299-2a8b-4530-a061-c6fd9cd1294c4
856987acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral TabletSCD2f6d0712-e756-49f2-a6b8-bbd160a454c44
856987acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral TabletSCDc648e299-2a8b-4530-a061-c6fd9cd1294c4
856992acetaminophen 300 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDc648e299-2a8b-4530-a061-c6fd9cd1294c4
856980APAP 300 MG / hydrocodone bitartrate 10 MG Oral TabletSYc648e299-2a8b-4530-a061-c6fd9cd1294c4
856987APAP 300 MG / hydrocodone bitartrate 5 MG Oral TabletSY2f6d0712-e756-49f2-a6b8-bbd160a454c44
856987APAP 300 MG / hydrocodone bitartrate 5 MG Oral TabletSYc648e299-2a8b-4530-a061-c6fd9cd1294c4
856992APAP 300 MG / Hydrocodone Bitartrate 7.5 MG Oral TabletSYc648e299-2a8b-4530-a061-c6fd9cd1294c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71930-042-1271930004212100 TABLET in 1 BOTTLE (71930-042-12) 100 tablet2019-06-170000-00-00NoNoCurrent
71930-042-5271930004252500 TABLET in 1 BOTTLE (71930-042-52) 500 tablet2019-06-170000-00-00NoNoCurrent